Recombinant saccharomyces-fermentum-expressed hepatitis B surface antigen, production method of hepatitis B surface antigen, hepatitis B vaccine and production method of hepatitis B vaccine

Abstract

The invention discloses a production method of a recombinant saccharomyces-fermentum-expressed hepatitis B surface antigen. The method comprises the steps of: circularly removing triton from an extracted antigen by using XAD-4 column, so as to obtain triton-removed antigen sample liquid; loading macroporous silica gel with the pore size of 1,000 A and the particle size of 35-70 microns into a chromatographic column, and balancing by using phosphoric acid buffer solution with the pH of 7.6+ / -0.2; adjusting the pH of the triton-removed antigen sample liquid to be 7.6+ / -0.2 by using NaOH, then, loading a sample to the macroporous silica gel column; and cleaning impurities by using phosphoric acid buffer solution with the pH of 7.2+ / -0.2, carrying out eluting treatment on the impurity-cleaned macroporous silica gel column by using boric acid buffer solution with the pH of 8.7+ / -0.2 at the temperature of 47-49 DEG C, collecting eluate, and carrying out ultrafiltration and concentration on the eluate, thereby obtaining a clarified antigen. The invention further discloses the corresponding recombinant saccharomyces-fermentum-expressed hepatitis B surface antigen, a hepatitis B vaccine and a production method of the hepatitis B vaccine. The production methods have the advantages that the probability of product contamination is reduced greatly, the labor intensity for laborers is reduced, the equipment investment and repairing cost are reduced, the space occupied by equipment is reduced, and the production time is shortened.

Description

technical field [0001] The invention relates to biopharmaceutical technology, in particular to a hepatitis B surface antigen expressed by recombinant brewer's yeast and a production method thereof, a hepatitis B vaccine and a production method thereof. Background technique [0002] Hepatitis B virus (HBV) is a DNA virus. HBV infection is prevalent worldwide, but the prevalence of HBV infection varies greatly in different regions. According to the report of the World Health Organization, about 2 billion people in the world have been infected with HBV, of which 350 million people are chronic HBV infected people, and about 1 million people die every year from liver failure, liver cirrhosis and primary hepatocellular carcinoma caused by HBV infection . [0003] my country is a high-prevalence area of ​​hepatitis B, with an average of more than 500,000 cases reported each year. For many years, the incidence and incidence rate of hepatitis B have been at the forefront of the leg...

AI Technical Summary

Problems solved by technology

In this rough purification process, 8 to 10 large-capacity medium-speed centrifuges must be used, and the production operation time is 4 days. The manual operation is intensive, and the process cannot be completely completed in a closed system.

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